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The study design was changed.
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The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.
Patients are randomly assigned to the empirical therapy group and tailored therapy group.
The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.
Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empirical therapy for H. pylori infection | Active Comparator | The empirical group receives triple therapy of 7 or 14 days for H. pylori eradication |
|
| Tailored therapy for H. pylori infection | Experimental | The tailored therapy group receives eradication regimens based on their DPO-PCR results. Triple therapy of 7 or 14 days for clarithromycin sensitive patients based on DPO-PCR and bismuth quadruple therapy of 7 or 14 days for clarithromycin resistant patients based on DPO-PCR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) | Diagnostic Test | Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results |
| Measure | Description | Time Frame |
|---|---|---|
| Eradication success | H. pylori eradication success based on urea breath test | 8-12 weeks after eradication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byung-Wook Kim, MD, PhD | Incheon St.Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Incheon St. Mary's Hospital | Incheon | South Korea |
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Empirical treatment versus tailored therapy
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